(60 days)
The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.
The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed to create a subcutaneous tunnel to temporarily bury the external portion of the peritoneal dialysis catheter within the abdominal, subcutaneous tissue in advance of needing dialysis.
The tunneling device is made of stainless steel with a rigid plastic handle on the proximal end. There is an angled tip with a removable plastic cap. Functioning as a dilator, the tunneling device separates the tissue to create a tunnel tract, then is used to pull the catheter through the tunnel to desired exit site.
The titanium catheter plug is designed to seal the end of the catheter for the length of time that the catheter is buried within the subcutaneous tissue.
This is not an AI/ML device, therefore, the requested information is not applicable.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.